The HCPFive: Top News for Healthcare Providers from the Week of 04/12

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration (FDA) approval of sparsentan (Filspari) for the treatment of focal segmental glomerulosclerosis (FSGS), positive topline phase 2 data for SPY001 in ulcerative colitis, the FDA acceptance of a supplemental New Drug Application (sNDA) for delgocitinib (Anzupgo) cream for the treatment of moderate-to-severe chronic hand eczema in adolescents aged 12 to 17 years, the discontinuation of Insmed Incorporated’s brensocatib development program in hidradenitis suppurativa, and the tentative FDA approval of a generic semaglutide injection submitted by Apotex Corp.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of April 12, 2026—let’s jump in!

FDA Approves Sparsentan for Focal Segmental Glomerulosclerosis

On April 13, 2026, the FDA granted full approval to Travere Therapeutics’ sparsentan (Filspari) for the treatment of FSGS, supported by data from 2 of the largest head-to-head interventional studies in adult and pediatric patients with FSGS, the phase 3 DUPLEX study and the phase 2 DUET study. The decision makes sparsentan the first and only drug approved for this indication.

SPY001, An Anti-α4β7, Shows Promise in Phase 2 SKYLINE Trial for Ulcerative Colitis

On April 13, 2026, Spyre Therapeutics announced positive 12-week induction data from Part A of the phase 2 SKYLINE trial of SPY001, a potential best-in-class anti-α4β7 being investigated for the treatment of moderate-to-severely active UC. The Company additionally announced that recruitment for Part A of SKYLINE is now closed and enrollment is open for Part B, which includes 3 monotherapy cohorts (SPY001, SPY002, and SPY003) and 3 combination cohorts (SPY120, SPY130, and SPY230) into which participants may be randomized versus a shared placebo. Proof-of-concept induction data for the remaining cohorts of Part A are now expected mid-2026 (SPY002) and Q3 2026 (SPY003), while Part B induction data for all cohorts remain on track for 2027.

FDA Accepts Delgocitinib sNDA for Chronic Hand Eczema in Adolescents Aged 12–17

On April 15, 2026, the FDA accepted an sNDA for delgocitinib (Anzupgo) cream for the treatment of moderate-to-severe chronic hand eczema in adolescents aged 12 to 17 years. The filing acceptance marks the first regulatory review pathway in the United States specifically targeting the pediatric age group for chronic hand eczema and comes less than 1 year after delgocitinib cream became the first therapy to receive FDA approval for chronic hand eczema in adults in July 2025.

Brensocatib Phase 2b Study in HS Does Not Meet Endpoints, Program Discontinued

Insmed Incorporated announced that the phase 2b CEDAR study evaluating brensocatib in adult patients with moderate to severe hidradenitis suppurativa did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg treatment arms. Based on these data, Insmed indicated plans to discontinue its development program of brensocatib in this disease state and to present these data at a future congress.

FDA Gives Tentative Approval of ANDA for Generic Semaglutide Injection

The FDA announced its tentative approval of an Abbreviated New Drug Application (ANDA) for a generic semaglutide injection submitted by Apotex Corp. The decision marks a regulatory step toward potential generic competition in the GLP-1 RA class. However, the approval does not permit immediate marketing but indicates that the application meets FDA standards for quality, safety, and efficacy, pending resolution of patent or exclusivity barriers.